Compare CPM-RMI trial: intramyocardial transplantation of autologous bone marrow-derived cd133+ cells and mononuclear cells during coronary artery bypass grafting in patients with recent myocardial infarction: a phase II/III, multicenter, placebo-controlled, randomized, double-blind clinical trial

Objective: The regenerative potential of bone marrow-derived mononuclear cells [MNCs] and CD133+ stem cells in the heart varies in terms of their pro-angiogenic effects. This phase II/III, multicenter and double-blind trial is designed to compare the functional effects of intramyocardial autologous transplantation of both cell types and placebo in patients with recent myocardial infarction [RMI] post-coronary artery bypass graft

Materials and Methods: This was a phase II/III, randomized, double-blind, placebo-controlled trial COMPARE CPM-RMI [CD133, Placebo, MNCs - recent myocardial infarction] conducted in accordance with the Declaration of Helsinki that assessed the safety and efficacy of CD133 and MNCs compared to placebo in patients with RMI. We randomly assigned 77 eligible RMI patients selected from 5 hospitals to receive CD133+ cells, MNC, or a placebo. Patients underwent gated single photon emission computed tomography assessments at 6 and 18 months post-intramyocardial transplantation. We tested the normally distributed efficacy outcomes with a mixed analysis of variance model that used the entire data set of baseline and between-group comparisons as well as within subject [time] and group×time interaction terms

Results: There were no related serious adverse events reported. The intramyocardial transplantation of both cell types increased left ventricular ejection fraction by 9% [95% confidence intervals [CI]: 2.14% to 15.78%, P=0.01] and improved decreased systolic wall thickening by -3.7 [95% CI: -7.07 to -0.42, P=0.03]. The CD133 group showed significantly decreased non-viable segments by 75% [P=0.001] compared to the placebo and 60% [P=0.01] compared to the MNC group. We observed this improvement at both the 6- and 18-month time points

Conclusion: Intramyocardial injections of CD133+ cells or MNCs appeared to be safe and efficient with superiority of CD133+ cells for patients with RMI. Although the sample size precluded a definitive statement about clinical outcomes, these results have provided the basis for larger studies to confirm definitive evidence about the efficacy of these cell types

Pregnancy outcome after mechanical mitral valve replacement: a prospective study

Pregnant patients with mechanical heart valves require anticoagulation. The risk of bleeding and embryopathy associated with oral anticoagulants must be weighed against the risk of valve thrombosis. In this prospective study, undertaken between 1999 and 2009, 53 pregnancies [47 women with mechanical mitral valves; 29.8 +/- 4.8 years old] were studied. Patients were divided into two groups: group I [n = 43] received Warfarin throughout the pregnancy, while group II [n = 10] received Heparin in the first trimester and then Warfarin until the 36th week. Thirty-two [60.4%] pregnancies resulted in live births, whereas 18 [34%] abortions, 2 [3.8%] stillbirths, and one [1.9%] maternal death occurred. In group I, there were 26 [60.5%] live births, one [2.3%] stillbirth, and 15 [34.9%] abortions. In group II, there were 6 [60%] live births, one [10%] stillbirth, and 3 [30%] abortions. There were no significant differences between the two groups in terms of fetal outcome. Thirty-nine [90.7%] of the pregnancies in group I and 50% of those in group II [p value = 0.001] were without complications. There were no congenital malformations in the two groups. Fetal outcome was almost the same between the Warfarin and Heparin regimens. In maternal outcome, the Warfarin regimen is safer than Heparin

Anti-coagulation during pregnancy in women with mechanical heart valves: a prospective study

Pregnancy is associated with a hypercoagulable state, therefore the optimal anticoagulants for potential use in pregnant women with prosthetic heart valves are controversial. The aim of this study is to investigate the effect of anticoagulants on pregnancy outcomes and their potential risks in pregnant women with mechanical heart valves. In this prospective cohort study, we followed 44 women with 49 pregnancies who had mechanical heart valves from September 2002 to September 2007. A total of 38 patients took warfarin throughout their pregnancies [group A]. In 11 patients, warfarin was changed to heparin during the first trimester and then again to warfarin during 12[th] to 36[th] weeks of gestational age [group B]. All women took warfarin from 36[th] weeks of gestational age until deliver. In group A, there were 22 live births [57.9%], 15 abortions [39.5%] and 1 maternal death [2.6%]. In group B, there were seven live births [63.6%], three spontaneous abortions [27.3%] and one intra-uterine fetal death [9.1%]. There was no significant difference in live birth rate between the two groups [p=0.24]. Thirty-three pregnancies [86.8%] in group A and five pregnancies [45.4%] in group B had no maternal complications [p=0.004]. The difference in pregnancy complications between both groups was significant [p<0.001]. The present study shows that low dose warfarin [5 mg/day or less] may be safe during the first trimester of pregnancy. Maternal adverse events are low when pregnant women with mechanical heart valves remain on a warfarin regimen. The risk of embryopathy doe not necessarily increase

Symptoms of natural menopause among Iranian women living in Tehran, Iran

Menopause is a step of a woman's life when hormonal changes cause menstruation to stop permanently. Menopausal symptoms can affect women's health and differ between different races and societies. The aim of this study was to survey the symptoms associated with menopause among Iranian women living in Tehran, Iran. In this cross sectional study which has been done between 2004 and 2005, women aged equal or more than 35 years old living in districts of Tehran were selected by multistage randomized cluster sampling. For each woman a questionnaire was completed. The data gained from each questionnaire was analyzed by using SPSS version 13. At time of study, 2462 women were naturally menopause. The mean age of natural menopause onset was 47.71 [SE=0.11] years. In 52.9% of cases, the onset of menopause was sudden. The symptoms associated with menopause were night sweats [61.2%], joint and muscle pain [59.9%], hot flashes [53.1%], fatigue [45.6%], decreased libido [33.9%], insomnia [33.7%], weight gain [30.1%], forgetfulness [24.9%] and urinary symptoms [17.4%]. This study showed that night sweats, joint and muscle pain and hot flashes are the most common symptoms associated with menopause

Outcome of anesthesia and open heart surgery in pergnant patients

Cardiovascular disease is an important non-obstetric cause of maternal and fetal /neonatal morbidity and mortality during pregnancy. For a pregnant woman with cardiac disease, the potential inability of the maternal cardiovascular system to contend with normal pregnancy-induced physiologic changes may produce deleterious effects on both mother and fetus. To determine the most frequent surgical indications of maternal and fetal mortality, we studied 15 cases of severe cardiac disease in pregnant women who required cardiac surgical procedures. In this descriptive study, fifteen pregnant women who underwent cardiac surgery were studied. Maternal age ranged from 27 to 36 years, and gestational age varied from 4 to 22 weeks. Most of the patients were in New York Heart Association Classes II and III. Opioid- based anesthesia with fentanyl citrate [50 micro/kg] or sufentanil [5 micro/kg] plus low dose of thiopental were used for the induction of anesthesia. During non-pulsatile cardio-pulmonary bypass, core temperature was between 28-36 °C, average CBP time was 61.2 +/- 22 min, average aortic cross-clamp time was 34.13 +/- 14 min, and mean pump pressure was maintained between 65-80 mmHg. Ten patients had severe mitral valve disease [66.6%], three had aortic valve disease [20%], one had subvalvular aortic stenosis [6.7%], and the remaining one had left atrial myxoma [6.7%]. There were five fetal deaths [33.3%] and one maternal death [6.7%]. It seems that open heart surgery in the first trimester is very hazardous for the fetus and may lead to fetal death. If possible, surgery should be carried out in the second trimester of pregnancy. The recommendations are simply guidelines because research data and clinical experience in this area are limited